Abstract
PurposeRadioembolization has emerged as a treatment modality for patients with primary and secondary liver tumours. This observational study CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France) aims to evaluate real-life clinical practice on all patients treated with transarterial radioembolization (TARE) using SIR-Spheres yttrium-90 resin microspheres in France. In this interim analysis, safety and quality of life data are presented. Final results of the study, including secondary effectiveness outcomes, will be published later. Overall, CIRT-FR is aiming to support French authorities in the decision making on reimbursement considerations for this treatment.MethodsData on patients enrolled in CIRT-FR from August 2017 to October 2019 were analysed. The interim analysis describes clinical practice, baseline characteristics, safety (adverse events according to CTCTAE 4.03) and quality of life (according to EORTC QLQ C30 and HCC module) aspects after TARE.ResultsThis cohort included 200 patients with hepatocellular carcinoma (114), metastatic colorectal cancer (mCRC; 38) and intrahepatic cholangiocarcinoma (33) amongst others (15). TARE was predominantly assigned as a palliative treatment (79%). 12% of patients experienced at least one adverse event in the 30 days following treatment; 30-day mortality was 1%. Overall, global health score remained stable between baseline (66.7%), treatment (62.5%) and the first follow-up (66.7%).ConclusionThis interim analysis demonstrates that data regarding safety and quality of life generated by randomised-controlled trials is reflected when assessing the real-world application of TARE.Trial RegistrationClinical Trials.gov NCT03256994.
Highlights
Transarterial radioembolization (TARE), known as selective internal radiation therapy (SIRT), with SIRSpheres Y-90 resin microspheres, is an endovascular procedure included within the interventional oncologic armamentarium to treat primary and secondary liver tumours [1,2,3,4,5,6,7].CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France; NCT03256994) was developed as a France-only adaptation of the pan-European, prospective observational study CIRT (NCT02305459) [8]
This observational study CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France) aims to evaluate real-life clinical practice on all patients treated with transarterial radioembolization (TARE) using SIR-Spheres yttrium-90 resin microspheres in France
Regarding the real-life clinical use of TARE in France, treatment intent varied across observed indications and was largely used as a palliative or first line treatment for hepatocellular carcinoma (HCC)
Summary
Transarterial radioembolization (TARE), known as selective internal radiation therapy (SIRT), with SIRSpheres Y-90 resin microspheres, is an endovascular procedure included within the interventional oncologic armamentarium to treat primary and secondary liver tumours [1,2,3,4,5,6,7].CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France; NCT03256994) was developed as a France-only adaptation of the pan-European, prospective observational study CIRT (NCT02305459) [8]. Under the condition that the present study was conducted in order to collect data on the real-life clinical application of TARE with SIR-SpheresÒ in France, reimbursement for liveronly metastatic colorectal cancer (mCRC) was granted for 5 years by the French national health authorities Autoritede Sante, HAS) in March 2017.1 In March 2019, based on the results of the phase III randomized controlled trials SARAH [10] and SIRveNIB [11], HAS extended reimbursement for patients with intermediate or advanced hepatocellular carcinoma (HCC2). Final data from this observational study will support French authorities in the decision making on reimbursement considerations for TARE beyond 2022. This publication is the 200-patient interim analysis of the prospective, post-market, observational study CIRTFR, with the objective to report on patient characteristics, treatment details as well as safety and health-related quality of life
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